DNA Exome Sequencing TCM for Sjögren's Syndrome

NCT ID: NCT03935373

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-12-31

Brief Summary

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To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome

Detailed Description

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Objective: To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome

Method:

This study wants to establish the reference value of DNA gene variants of healthy control for comparing with the Sjögren's syndrome subjects. And the investigators want to use the DNA Exome sequencing tools, proteomics and oral microbiome to explore the association of gene expression between at least 30 Sjögren's syndrome subjects and at least 10 healthy control subjects. Finally, the investigators also analyze the association among gene expression, proteomics and oral microbiome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and heart rate variability (HRV) for this purpose.

Expected Results:

1. To evaluate the difference among TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and HRV for the Sjögren's syndrome and healthy control.
2. To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.
3. To evaluate the proteomics for the Sjögren's syndrome and healthy control.
4. To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.
5. To evaluate the association among the immunity-related gene expression, SSA, SSB and RF.

Keyword: Sjögren's syndrome, Immune regulation, Gene modulation, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, proteomics, oral microbiome

Conditions

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Sjögren's Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sjögren's syndrome

Sjögren's syndrome patients were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) primary or secondary SS; (2) aged between 20 and 75 years; (3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG); (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; or (3) steroid pulse therapy within three months prior to the commencement of our study.

DNA Exome sequencing

Intervention Type DIAGNOSTIC_TEST

The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.

Oral microbiome

Intervention Type DIAGNOSTIC_TEST

The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.

Proteomics

Intervention Type DIAGNOSTIC_TEST

The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.

RNA sequencing

Intervention Type DIAGNOSTIC_TEST

The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.

Cytokine

Intervention Type DIAGNOSTIC_TEST

The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.

Traditional Chinese Medicine pattern

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.

Traditional Chinese Medicine tongue diagnosis

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.

Traditional Chinese Medicine pulse diagnosis

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.

Heart rate variability

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the heart rate variability.

Schirmer's test

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients will take the Schirmer's test.

Blood function test, liver function test, kidney function test, and immune function test

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)

Health subjects

Health subjects were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) aged between 41 and 63 years (which the age could match the SS patients enrolling in the SS-1 trial); (2) had no chronic inflammatory illness. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; (3) abnormal findings of immune, liver, kidney, or blood function evaluations; (4) total sleeping time insufficiency less than 6 hours before one day of enrollment; (5) ever took the conventional medicine or hormone within one month; (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.

DNA Exome sequencing

Intervention Type DIAGNOSTIC_TEST

The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.

Oral microbiome

Intervention Type DIAGNOSTIC_TEST

The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.

Proteomics

Intervention Type DIAGNOSTIC_TEST

The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.

RNA sequencing

Intervention Type DIAGNOSTIC_TEST

The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.

Cytokine

Intervention Type DIAGNOSTIC_TEST

The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.

Traditional Chinese Medicine pattern

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.

Traditional Chinese Medicine tongue diagnosis

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.

Traditional Chinese Medicine pulse diagnosis

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.

Heart rate variability

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the heart rate variability.

Blood function test, liver function test, kidney function test, and immune function test

Intervention Type DIAGNOSTIC_TEST

Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)

Interventions

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DNA Exome sequencing

The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.

Intervention Type DIAGNOSTIC_TEST

Oral microbiome

The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.

Intervention Type DIAGNOSTIC_TEST

Proteomics

The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.

Intervention Type DIAGNOSTIC_TEST

RNA sequencing

The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.

Intervention Type DIAGNOSTIC_TEST

Cytokine

The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.

Intervention Type DIAGNOSTIC_TEST

Traditional Chinese Medicine pattern

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.

Intervention Type DIAGNOSTIC_TEST

Traditional Chinese Medicine tongue diagnosis

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.

Intervention Type DIAGNOSTIC_TEST

Traditional Chinese Medicine pulse diagnosis

Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.

Intervention Type DIAGNOSTIC_TEST

Heart rate variability

Sjögren's syndrome patients and health subjects will take the heart rate variability.

Intervention Type DIAGNOSTIC_TEST

Schirmer's test

Sjögren's syndrome patients will take the Schirmer's test.

Intervention Type DIAGNOSTIC_TEST

Blood function test, liver function test, kidney function test, and immune function test

Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* (1) primary or secondary SS
* (2) aged between 20 and 75 years
* (3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
* (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations.


* (1) aged 20 and 75 years
* (2) had no chronic inflammatory illness.

Exclusion Criteria

* (1)a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
* (2) pregnancy or breastfeeding
* (3) steroid pulse therapy within three months prior to the commencement of our study.

Health Subjects


* (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
* (2) pregnancy or breastfeeding
* (3) abnormal findings of immune, liver, kidney, or blood function evaluations
* (4) total sleeping time insufficiency less than 6 hours before one day of enrollment
* (5) ever took the conventional medicine or hormone within one month
* (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching-Mao Chang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Ching-Mao Chang

Taipei, Taiwan (r.o.c.), Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2017-09-006C#3

Identifier Type: -

Identifier Source: org_study_id

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